Myocardial Infarction

• FDA label_change · 2024-11-13
  FDA Approved: METOPROLOL — Supplemental Application (Fresenius Kabi USA, LLC)

  FDA approved a supplemental application for Metoprolol Tartrate from Fresenius Kabi USA, LLC, indicating approved changes to labeling or for…

• FDA label_change · 2021-09-15
  FDA Approved: METOPROLOL — Supplemental Application (Fresenius Kabi USA, LLC)

  FDA approved a supplemental application for metoprolol tartrate products from Fresenius Kabi USA, LLC.

• FDA label_change · 2020-04-08
  FDA Approved: VALSARTAN — Supplemental Application (Macleods Pharmaceuticals Limited)

  The FDA approved a supplemental application for valsartan from Macleods Pharmaceuticals Limited, indicating changes to the product labeling.

• FDA label_change · 2016-09-07
  FDA Approved: AGGRASTAT — Supplemental Application (Medicure International Inc)

  FDA approved a supplemental application for AGGRASTAT (tirofiban) submitted by Medicure International Inc, resulting in changes to the produ…

• FDA label_change · 2016-02-18
  FDA Approved: LISINOPRIL — Supplemental Application (Exelan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for lisinopril submitted by Exelan Pharmaceuticals Inc., typically resulting in labeling updates…

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• FDA label_change · 2015-09-03
  FDA Approved: BRILINTA — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  FDA approved a supplemental application for Brilinta (ticagrelor) filed by AstraZeneca, resulting in a labeling update for the drug.

• FDA label_change · 2014-09-26
  FDA Approved: CARVEDILOL — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)

  The FDA approved a supplemental application for carvedilol submitted by Glenmark Pharmaceuticals USA, resulting in changes to the drug’s lab…

• FDA label_change · 2013-11-05
  FDA Approved: ZESTRIL — Supplemental Application (Upsher-Smith Laboratories, LLC)

  FDA approved a supplemental application for ZESTRIL (lisinopril) submitted by Upsher-Smith Laboratories, LLC.

• FDA label_change · 2012-10-31
  FDA Approved: ZESTRIL — Supplemental Application (Upsher-Smith Laboratories, LLC)

  The FDA approved a supplemental application for Zestril (lisinopril) from Upsher-Smith Laboratories, resulting in updated labeling.

• FDA label_change · 2008-08-14
  FDA Approved: ENALAPRIL MALEATE — Supplemental Application (Amici Pharma, Inc)

  FDA approved a supplemental application for enalapril maleate from Amici Pharma, Inc., resulting in labeling changes for the product.

• FDA label_change · 2007-03-14
  FDA Approved: TOPROL XL — Supplemental Application (Melinta Therapeutics, LLC)

  FDA approved a supplemental application for TOPROL XL (metoprolol succinate) submitted by Melinta Therapeutics, LLC.

• FDA label_change · 2006-12-20
  FDA Approved: COREG — Supplemental Application (Waylis Therapeutics LLC)

  The FDA approved a supplemental application for COREG (carvedilol) submitted by Waylis Therapeutics LLC. The approval indicates an update to…